Penicillin break: major trial tests if kids with mild RHD can ditch daily antibiotics

NCT ID NCT07146048

Recruiting now Disease control Sponsor: Children's Hospital Medical Center, Cincinnati Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial will test whether children and teens with mild rheumatic heart disease (RHD) can safely stop taking long-term penicillin. About 922 participants aged 5-20 who have stable or normalized RHD after at least 2 years of antibiotics will be randomly assigned to either continue or stop penicillin. Researchers will track if their heart condition gets worse over 2 years using echocardiograms.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: penicillin (antibiotic prophylaxis)
What this could lead to: If successful, this could show that some children with mild rheumatic heart disease can safely stop long-term penicillin without their heart condition getting worse.
What could go wrong: This is a non-inferiority trial, so it is designed to show that stopping is not worse than continuing. Even if it succeeds, the results may only apply to children with very mild or normalized disease, and longer follow-up may reveal risks.

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Conditions

The condition(s) this trial relates to.

rheumatic heart disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

RHEUMATIC HEART DISEASE

Contacts and locations

Locations

Uganda Heart Institute
RECRUITING

Kampala, UG, Uganda

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